PHARMACEUTICAL RESEARCH SHARED RESOURCE David Adams, Ph.D., Ashley Morris-Engemann, Pharm.D., Co-Directors The Pharmaceutical Research Shared Resource consists of an lnvestigational Chemotherapy Service and a Cancex Clinical Pharmacology Laboratory, provides a broad range of services to support the conduct of clinical hematology/ontology research. The Investigational Chemotherapy Service (ICS) is available to all Cancer Center investigators for the purpose of maintaining drug accotmtability records and investigafional drug inventories according to FDA and CTEP guidelines. In addition, this resource provides design consultation, professional staff education, and implementation services for clinical research studies. The primary focus of the Clinical Pharmacology Lab (CPL) is to investigate the pharmacokinetics and pharmacodynamics of anticancer drugs and recombinant proteins used in the experimental therapy of cancer. This resource is also available for analysis of endogenous cytokine concentrations during investigational therapy. One of the major goals of the laboratory is to identify predictors of response and toxicity and implement methods to reduce inter-patient variability of drug exposure. The lab provides both consultative and analytic services regarding clinical pharmacokinetie studies of anticancer compounds and recombinant proteins. These include: aid with trial design, optimal sampling techniques, sample handling and stability, quantitative measurement of drug and metabolite concentrations (via HPLC, atomic absorption spcetrophotometry, gas chromatography/mass spectrophotometry, or ELISA), calculation of individual and population pharmacokinetic parameters and pharmacometric evaluation via sophisticated computer modeling programs. This resource has maintained a high level of usage by Cancer Center investigators including those from the Experimental Therapeutics Program, Breast and Ovarian Bone Marrow Radiation and Ontology, Transplantation, Neuro-Oncology, Oncology Hyperthermia, and Cancer Immtmobiology Programs. During the last fiscal year, 100% of the resource utilization was generated for peer-reviewed investigators.